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Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs — PACUTI  

Urinary Tract Infections Clinical Trial

Official title:
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI)

Clinical Trial Summary

To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).

Clinical Trial Description

A recent observational cohort study supports the notion that beta-lactams can be used with similar efficacy to fluoroquinolones as step down therapy in bacteremic E. coli UTI's. As such, pivmecillinam clavulanic acid (PAC) constitute an appealing per oral alternative, but the combination's safety and efficacy has not been evaluated in a clinical trial The aim of this trial is to investigate whether the PAC combination is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in treating EPE-causing febrile UTI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05224401
Study type Interventional
Source Lund University
Contact Oskar Ljungquist, M.D, PhD
Phone +46424063182
Email oskar.ljungquist@med.lu.se
Status Recruiting
Phase Phase 3
Start date May 29, 2023
Completion date September 1, 2027
View Details
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